NICE approves quadruplet DVRD for newly diagnosed transplant-ineligible patients
A new quadruplet treatment that could give newly diagnosed patients remissions of more than four years has been approved on the NHS in England and Wales.
The National Institute for Health and Care Excellence (NICE) approved DVRD for the treatment of newly diagnosed patients who are not eligible for a stem cell transplant. It combines daratumumab (Darzalex®), bortezomib (Velcade®), lenalidomide (Revlimid®) and dexamethasone.
Around 3,300 people are expected to receive this life-extending treatment each year.
The approval is a big win for the myeloma community after DVRD was initially knocked back by the NICE over uncertainty around cost-effectiveness.
Myeloma UK submitted more data and evidence to NICE’s appraisal committee and, along with clinicians and the pharmaceutical company behind the treatment, successfully made the case for DVRD to be rolled out on the NHS.
DVRD is the second quadruplet treatment for people ineligible for a stem cell transplant, and because daratumumab is given as an injection and moves to monthly dosing after 8 cycles, it gives patients access to a more convenient treatment option.
The approval data from the Phase 3 CEPHEUS trial, which compared DVRD to the triplet combination of bortezomib, lenalidomide and dexamethasone (VRD), showed that 68% of people on DVRD were still in remission after four and a half years.
Caroline Donoghue, Access Manager at Myeloma UK, said:
“This is fantastic news and a great result for patients who felt let down by NICE’s initial decision not to approve DVRD. Myeloma UK have been working very hard to get NICE to reconsider and we’re delighted they’ve agreed to roll it out on the NHS. We know how devastating being diagnosed with myeloma is and new patients deserve the best possible treatment right from the off.
“Not only does DVRD have the potential to keep myeloma at bay for more than four years, but it means less time spent in hospital for people with myeloma and their families. We can’t emphasise enough what this means for their quality of life.
“Our work is far from over and we’ll keep pushing until NICE approves DVRD for all newly diagnosed patients, regardless of whether they can have a stem cell transplant.
“Until we have a cure, it is absolutely vital that people with myeloma get the treatment they need as soon as they’re diagnosed.”
Myeloma UK continues to work to seek access to DVRD for newly diagnosed, transplant-eligible patients. The NICE appraisal for the use of the quadruplet in this patient population is ongoing, with a third committee meeting due to take place on 17 June. A key challenge for this appraisal has been the MRD stopping rule and modelling how it will be implemented in clinical practice.
We have provided evidence and testimony throughout the appraisal, highlighting what the extended remission times mean for people living with myeloma as well as working with clinicians, MRD experts and the pharmaceutical company to confirm the feasibility of MRD testing in the NHS.
Daratumumab belongs to a group of drugs known as monoclonal antibodies and works by attaching to a protein present on the surface of myeloma cells. This flags the cell to the immune system and allows it to target and kill the myeloma cell.
Q&A
What is DVRD?
DVRD is a combination treatment used to treat myeloma. It contains four drugs: daratumumab, bortezomib, lenalidomide and dexamethasone. All the drugs in the combination are already being used to treat myeloma, but are used in different combinations.
DVRD is given in two phases: induction and maintenance. In the induction phase, patients get all four drugs. In the maintenance phase, patients come off bortezomib and continue with DRD.
NICE is currently deciding whether to approve DVRD for newly diagnosed patients who are eligible for a stem cell transplant on the NHS. For transplant-eligible patients, DVRD is given in three phases: induction, consolidation and maintenance. In the induction and consolidation phases, patients get all four drugs. In the maintenance phase, patients come off bortezomib and dexamethasone and continue taking daratumumab and lenalidomide as maintenance. Patients who have been on maintenance for at least 24 months and have had no detectable myeloma cells in the blood or bone marrow for at least 12 months can then come off daratumumab.
What about people living in Scotland and Northern Ireland?
In Scotland, the Scottish Medicines Consortium makes decisions about which treatments to fund through the NHS. The SMC appraisal for DVRD is due to start later this year.
In Northern Ireland, the Department for Health makes decisions on which treatments to fund through the NHS. It can follow guidance issued by either NICE or the SMC, but usually follows the guidance issued by NICE.
Useful resources
- NICE guidance: Daratumumab with bortezomib, lenalidomide and dexamethasone for untreated multiple myeloma when a stem cell transplant is unsuitable
- MHRA: Daratumumab summary of product characteristics (SPC)
- MHRA: Daratumumab patient information leaflet (PIL)
- MHRA: Bortezomib summary of product characteristics (SPC)
- MHRA: Bortezomib patient information leaflet (PIL)
- MHRA: Lenalidomide summary of product characteristics (SPC)
- MHRA: Lenalidomide patient information leaflet (PIL)
- MHRA: Dexamethasone summary of product characteristics (SPC)
- MHRA: Dexamethasone patient information leaflet (PIL)
